ASTM F2382-17e1
(Test Method)Standard Test Method for Assessment of Circulating Blood-Contacting Medical Device Materials on Partial Thromboplastin Time (PTT)
Standard Test Method for Assessment of Circulating Blood-Contacting Medical Device Materials on Partial Thromboplastin Time (PTT)
SIGNIFICANCE AND USE
4.1 The purpose of this test method is to determine the time citrated plasma exposed to medical materials takes to form a clot when exposed to a suspension of phospholipid particles and calcium chloride. In this test method, the test article is the activator. The PTT assay is a general screening test for a medical material’s ability to activate the intrinsic coagulation pathway. Material samples that show a shortened PTT are activators of the intrinsic coagulation pathway.
4.2 The test article, reference materials, and controls are exposed to human plasma. The plasma is tested on a coagulation device. Each sample tube is assayed in duplicate. The results are reported as a percentage of the negative control.
SCOPE
1.1 This test method covers the screening of circulating blood-contacting device materials for their ability to induce blood coagulation via the intrinsic coagulation pathway. This assay should be part of the hemocompatibility evaluation for devices and materials contacting human blood, as per ANSI/AAMI/ISO 10993-4.
1.2 All safety policies and practices shall be observed during the performance of this test method.
1.3 All plasma and any materials that had contact with plasma will be bagged in a biohazard bag, properly labelled with the contents, and disposed of by appropriate means. The plasma should be handled at the Biosafety Level 2 as recommended in the Centers for Disease Control/National Institutes of Health Manual Biosafety in Microbiological Laboratories.
1.4 The normal pooled human plasma must have tested negative for Hepatitis B (HBV) or Human Immunodeficiency (HIV) viruses. The plasmas should be treated like any patient plasma using standard precautions. The plasma should be handled at the Biosafety Level 2 as recommended in the Centers for Disease Control/National Institutes of Health Manual Biosafety in Microbiological Laboratories.
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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´1
Designation: F2382 − 17
Standard Test Method for
Assessment of Circulating Blood-Contacting Medical Device
1
Materials on Partial Thromboplastin Time (PTT)
This standard is issued under the fixed designation F2382; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1
ε NOTE—Corrected editorially in January 2018.
1. Scope ization established in the Decision on Principles for the
Development of International Standards, Guides and Recom-
1.1 This test method covers the screening of circulating
mendations issued by the World Trade Organization Technical
blood-contacting device materials for their ability to induce
Barriers to Trade (TBT) Committee.
blood coagulation via the intrinsic coagulation pathway. This
assay should be part of the hemocompatibility evaluation for
2. Referenced Documents
devices and materials contacting human blood, as per ANSI/
AAMI/ISO 10993-4.
2.1 ANSI/AAMI Standard:
ANSI/AAMI/ISO 10993-4 Biological Evaluation of Medical
1.2 All safety policies and practices shall be observed
Devices—Part 4: Selection of Tests for Interactions with
during the performance of this test method.
2
Blood
1.3 All plasma and any materials that had contact with
2.2 Other Document:
plasma will be bagged in a biohazard bag, properly labelled
U.S. Department of Health and Human Services Biosafety in
with the contents, and disposed of by appropriate means. The
Microbiological and Biomedical Laboratories (BMBL),
plasma should be handled at the Biosafety Level 2 as recom-
3
5th ed., 1999
mended in the Centers for Disease Control/National Institutes
of Health Manual Biosafety in Microbiological Laboratories.
3. Terminology
1.4 The normal pooled human plasma must have tested
3.1 Definitions of Terms Specific to This Standard:
negative for Hepatitis B (HBV) or Human Immunodeficiency
3.1.1 activator—a medical material which demonstrates a
(HIV) viruses. The plasmas should be treated like any patient
shortened clotting time; an initiator of the intrinsic coagulation
plasma using standard precautions. The plasma should be
pathway.
handled at the Biosafety Level 2 as recommended in the
3.1.2 partial thromboplastin time (PTT) assay—a modifica-
Centers for Disease Control/National Institutes of Health
tion of the Activated Partial Thromboplastin Time (APTT)
Manual Biosafety in Microbiological Laboratories.
assay; unlike the APTT test, the PTT assay uses reagent (rabbit
1.5 The values stated in SI units are to be regarded as
brain cephalin) without activating substances such as silica,
standard. No other units of measurement are included in this
kaolin, elagic acid. The material being tested acts as the
standard.
activator.
1.6 This standard does not purport to address all of the
3.1.3 read time—the time during which data is collected to
safety concerns, if any, associated with its use. It is the
detect a clot.
responsibility of the user of this standard to establish appro-
3.1.4 blank time—a period at the beginning of an assay
priate safety, health, and environmental practices and deter-
when no data is taken. This is done to eliminate interference
mine the applicability of regulatory limitations prior to use.
from premixing reagents, bubbles, and so forth.
1.7 This international standard was developed in accor-
3.1.5 equilibration time—the time allowed for the plasma
dance with internationally recognized principles on standard-
samples to warm to 37°C. The coagulation analyzer can be set
to zero if samples are pre-warmed to this temperature.
1
This test method is under the jurisdiction of ASTM Committee F04 on Medical
and Surgical Materials and Devices and is the direct responsibility of Subcommittee
2
F04.16 on Biocompatibility Test Methods. Available from American National Standards Institute (ANSI), 25 W. 43rd St.,
Current edition approved Sept. 1, 2017. Published September 2017. Originally 4th Floor, New York, NY 10036, http://www.ansi.org.
3
approved in 2004. Last previous edition approved in 2010 as F2382 – 04(2010). The BMBL 5th Edition (December 2009) is available from the Government
DOI: 10.1520/F2382-17E01. Printing Office or https://www.cdc.gov/biosafety/publications/bmbl5/bmbl.pdf
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
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F2382 − 17
3.1.6 duplicate flag—the agreement between the results of 8. Preparation of Apparatus
duplicate samples in percent. For example, if set to “15,” the
8.1 Prepare each test article, the negative reference
difference between the two channels must be
...
This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
´1
Designation: F2382 − 17 F2382 − 17
Standard Test Method for
Assessment of Circulating Blood-Contacting Medical Device
1
Materials on Partial Thromboplastin Time (PTT)
This standard is issued under the fixed designation F2382; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1
ε NOTE—Corrected editorially in January 2018.
1. Scope
1.1 This test method covers the screening of circulating blood-contacting device materials for their ability to induce blood
coagulation via the intrinsic coagulation pathway. This assay should be part of the hemocompatibility evaluation for devices and
materials contacting human blood, as per ANSI/AAMI/ISO 10993-4.
1.2 All safety policies and practices shall be observed during the performance of this test method.
1.3 All plasma and any materials that had contact with plasma will be bagged in a biohazard bag, properly labelled with the
contents, and disposed of by appropriate means. The plasma should be handled at the Biosafety Level 2 as recommended in the
Centers for Disease Control/National Institutes of Health Manual Biosafety in Microbiological Laboratories.
1.4 The normal pooled human plasma must have tested negative for Hepatitis B (HBV) or Human Immunodeficiency (HIV)
viruses. The plasmas should be treated like any patient plasma using standard precautions. The plasma should be handled at the
Biosafety Level 2 as recommended in the Centers for Disease Control/National Institutes of Health Manual Biosafety in
Microbiological Laboratories.
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility
of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of
regulatory limitations prior to use.
1.7 This international standard was developed in accordance with internationally recognized principles on standardization
established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued
by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
2. Referenced Documents
2.1 ANSI/AAMI Standard:
2
ANSI/AAMI/ISO 10993-4 Biological Evaluation of Medical Devices—Part 4: Selection of Tests for Interactions with Blood
2.2 Other Document:
U.S. Department of Health and Human Services Biosafety in Microbiological and Biomedical Laboratories (BMBL), 5th
3
ed., 1999
3. Terminology
3.1 Definitions of Terms Specific to This Standard:
3.1.1 activator—a medical material which demonstrates a shortened clotting time; an initiator of the intrinsic coagulation
pathway.
1
This test method is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.16 on Biocompatibility Test Methods.
Current edition approved Sept. 1, 2017. Published September 2017. Originally approved in 2004. Last previous edition approved in 20042010 as
F2382 – 04.F2382 – 04(2010). DOI: 10.1520/F2382-17.10.1520/F2382-17E01.
2
Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.
3
The BMBL 5th Edition (December 2009) is available from the Government Printing Office or https://www.cdc.gov/biosafety/publications/bmbl5/bmbl.pdf
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
´1
F2382 − 17
3.1.2 partial thromboplastin time (PTT) assay—a modification of the Activated Partial Thromboplastin Time (APTT) assay;
unlike the APTT test, the PTT assay uses reagent (rabbit brain cephalin) without activating substances such as silica, kaolin, elagic
acid. The material being tested acts as the activator.
3.1.3 read time—the time during which data is collected to detect a clot.
3.1.4 blank time—a period at the beginning of an assay when no data is taken. This is done to eliminate interference from
premixing reagents, bubbles, and so forth.
3.1.5 equilibration time—the time allowed for the plasma samples to warm to 37°C. The coagulation analyzer can
...
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